AI software that boosts detection of small brain lesions gains FDA clearance
New artificial intelligence-powered software said to improve the detection of small lesions on brain MR imaging was just granted clearance by the U.S. Food and Drug Administration.
The software— AiMIFY—is a collaboration between Bracco Diagnostics, a subsidiary of Bracco Imaging, and Subtle Medical, Inc., a company that specializes in harnessing the power of AI to improve image acquisition. The pair announced the clearance on Wednesday.
"This FDA clearance marks a significant milestone for our innovative product, showcasing its potential to transform MRI," Fulvio Renoldi Bracco, vice chairman and chief executive officer of Bracco Imaging S.p.A., said in a release. "By integrating Bracco's expertise in contrast imaging with Subtle Medical's cutting-edge deep-learning technology, we are poised to redefine diagnostic precision and efficiency, setting new standards in the field for the ultimate benefit of the patients."
"We partnered with Bracco to unlock the potential that AI brings to medical imaging. The FDA clearance represents a significant milestone for both companies, as we join forces to empower radiological professionals and improve outcomes for patients worldwide with this innovative AI-powered medical imaging solution,” Ajit Shankaranarayanan, PhD, chief product officer at Subtle Medical, added.
AiMIFY can enhance contrast imaging of the brain up to two times as much as a single dose of gadolinium-based contrast agents (GBCAs), providing greater detail of smaller, more difficult to detect lesions. It has proven itself to be beneficial across multiple scanners from different vendors, diverse patient datasets and varying imaging protocols.
The product received clearance as Class 2 software as a medical device (SaMD) for magnetic resonance imaging (MRI) of the brain.
Both Bracco and Subtle Medical will have booths showcasing the software at the upcoming annual meeting of the Radiological Society of North America (RSNA) in December.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.